# CMC OFFICER/SPECIALIST

- **Entreprise** : [PRODUCTLIFE GROUP](https://www.keejob.com/offres-emploi/entreprises/23145/productlife-group/)
- **Lieu** : Tunis, Tunisie
- **Type de contrat** : CDI
- **Niveau d'études** : Bac + 5
- **Expérience** : Entre 2 et 5 ans
- **Langues** : Français, Anglais
- **Métiers** : Pharmacien
- **Salaire** : 2500 - 3500 TND Mois
- **Date de publication** : 2023-04-30
- **Date d'expiration** : 2023-04-30
- **Référence Keejob** : 177274
- **Statut** : Offre expirée

## Description

* Prepares CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  * Reviews CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  * Defines strategies for writing documents,
  * Defines positioning for variation files,
  * Evaluates the conformity of CMC documents according to the state of the art, current guidelines, local requirements and customer directives by performing gap analysis of regulatory documents.
  * Advises on pharmaceutical development: analysis of validation or stability reports.
  * Proposes to the client a strategy for validation, choice of specifications, stability plan.
  * Analyses and/or writes scientific reports based on raw data provided by the client
  * Regulatory compliance: comparison of analytical techniques and/or manufacturing processes between the MA file and factory procedures.
  * Carries out continuous regulatory monitoring/regulatory intelligence and communicates this to the teams
  * Contributes to the support and training of newcomers and colleagues (methodology, feedback,  
tools)
  * Applies internal processes and templates as well as best practices of the profession
  * Reports any deviation or problem to his/her manager and proposes corrective or preventive actions
  * Contributes to the drafting of processes / procedures and templates to serve the performance of consulting activities

## Postuler

Cette offre n'est plus active. Page de l'offre : https://www.keejob.com/offres-emploi/177274/cmc-officerspecialist/

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Source : Keejob.com, le site de l'emploi en Tunisie.